NCT05369988

Brief Summary

Surgical hemostasis has become one of the fundamental principles for the advancement of surgery. The use of hemostatic agents is standard in many surgical specialties, although the lack of consensus or standardized classifications to determine intraoperative bleeding has led to their inappropriate selection on many occasions. The recommendations of international organizations highlight the need for a bleeding severity scale validated in clinical studies that allows selecting the hemostatic agent that best suits each case.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
259

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 6, 2022

Last Update Submit

May 6, 2022

Conditions

Surgical HemorrhageLiver CancerLiver Metastases

Keywords

Liver surgerySurgical hemostasis

Outcome Measures

Primary Outcomes (1)

  • To validate the VIBe scale.

    To validate the VIBe scale for intraoperative bleeding in liver surgery.

    30 days

Secondary Outcomes (2)

  • Usefulness of the scale

    30 days

  • Determine the relationship between type of bleeding and hemostatic used, the success rate of hemostatic measurements, and complications related to bleeding.

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This registry includes all the elderly patients operated on in the participating Spanish centers who underwent liver surgery in the period described and that meet the inclusion criteria.

You may qualify if:

  • Patients age ≥ 18, scheduled for liver surgery, by open or minimally invasive approach, regardless of diagnosis;
  • ASA score \<4
  • They have signed the informed consent.

You may not qualify if:

  • Patients with contraindications for liver surgery
  • Emergency surgical interventions
  • Patients \<18 years
  • Patients who have not signed the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mario Serradilla Martin

Zaragoza, 50008, Spain

Location

Daniel Aparicio Lopez

Zaragoza, 50012, Spain

Location

Related Publications (17)

  • American Society of Anesthesiologists Task Force on Perioperative Blood Management. Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management*. Anesthesiology. 2015 Feb;122(2):241-75. doi: 10.1097/ALN.0000000000000463. No abstract available.

    PMID: 25545654RESULT

  • Wright Jr. JR, Schachar, NS. Necessity is the mother of invention: William Stewart Halsted's addiction and its influence on the development of residency training in North America. Can J Surg. 2020 Jan 16;63(1):E13-E19. doi: 10.1503/cjs.003319.

    PMID: 31944636RESULT

  • Shander A, Van Aken H, Colomina MJ, Gombotz H, Hofmann A, Krauspe R, Lasocki S, Richards T, Slappendel R, Spahn DR. Patient blood management in Europe. Br J Anaesth. 2012 Jul;109(1):55-68. doi: 10.1093/bja/aes139. Epub 2012 May 24.

    PMID: 22628393RESULT

  • Society of Thoracic Surgeons Blood Conservation Guideline Task Force; Ferraris VA, Brown JR, Despotis GJ, Hammon JW, Reece TB, Saha SP, Song HK, Clough ER; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion; Shore-Lesserson LJ, Goodnough LT, Mazer CD, Shander A, Stafford-Smith M, Waters J; International Consortium for Evidence Based Perfusion; Baker RA, Dickinson TA, FitzGerald DJ, Likosky DS, Shann KG. 2011 update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists blood conservation clinical practice guidelines. Ann Thorac Surg. 2011 Mar;91(3):944-82. doi: 10.1016/j.athoracsur.2010.11.078.

    PMID: 21353044RESULT

  • Menkis AH, Martin J, Cheng DC, Fitzgerald DC, Freedman JJ, Gao C, Koster A, Mackenzie GS, Murphy GJ, Spiess B, Ad N. Drug, devices, technologies, and techniques for blood management in minimally invasive and conventional cardiothoracic surgery: a consensus statement from the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS) 2011. Innovations (Phila). 2012 Jul-Aug;7(4):229-41. doi: 10.1097/IMI.0b013e3182747699.

    PMID: 23123988RESULT

  • Kommu SS, McArthur R, Emara AM, Reddy UD, Anderson CJ, Barber NJ, Persad RA, Eden CG. Current Status of Hemostatic Agents and Sealants in Urologic Surgical Practice. Rev Urol. 2015;17(3):150-9.

    PMID: 26543429RESULT

  • Wright JD, Ananth CV, Lewin SN, Burke WM, Siddiq Z, Neugut AI, Herzog TJ, Hershman DL. Patterns of use of hemostatic agents in patients undergoing major surgery. J Surg Res. 2014 Jan;186(1):458-66. doi: 10.1016/j.jss.2013.07.042. Epub 2013 Aug 13.

    PMID: 23993203RESULT

  • Dimick JB, Chen SL, Taheri PA, Henderson WG, Khuri SF, Campbell DA Jr. Hospital costs associated with surgical complications: a report from the private-sector National Surgical Quality Improvement Program. J Am Coll Surg. 2004 Oct;199(4):531-7. doi: 10.1016/j.jamcollsurg.2004.05.276.

    PMID: 15454134RESULT

  • Shander A. Financial and clinical outcomes associated with surgical bleeding complications. Surgery. 2007 Oct;142(4 Suppl):S20-5. doi: 10.1016/j.surg.2007.06.025.

    PMID: 18019945RESULT

  • Christensen MC, Krapf S, Kempel A, von Heymann C. Costs of excessive postoperative hemorrhage in cardiac surgery. J Thorac Cardiovasc Surg. 2009 Sep;138(3):687-93. doi: 10.1016/j.jtcvs.2009.02.021. Epub 2009 Apr 19.

    PMID: 19698857RESULT

  • Stokes ME, Ye X, Shah M, Mercaldi K, Reynolds MW, Rupnow MF, Hammond J. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Serv Res. 2011 May 31;11:135. doi: 10.1186/1472-6963-11-135.

    PMID: 21627788RESULT

  • Levy JH, Dutton RP, Hemphill JC 3rd, Shander A, Cooper D, Paidas MJ, Kessler CM, Holcomb JB, Lawson JH; Hemostasis Summit Participants. Multidisciplinary approach to the challenge of hemostasis. Anesth Analg. 2010 Feb 1;110(2):354-64. doi: 10.1213/ANE.0b013e3181c84ba5. Epub 2009 Dec 10.

    PMID: 20007735RESULT

  • Filipescu DC, Stefan MG, Valeanu L, Popescu WM. Perioperative management of antiplatelet therapy in noncardiac surgery. Curr Opin Anaesthesiol. 2020 Jun;33(3):454-462. doi: 10.1097/ACO.0000000000000875.

    PMID: 32371645RESULT

  • Schuhmacher C, Pratschke J, Weiss S, Schneeberger S, Mihaljevic AL, Schirren R, Winkler M, Emmanouilidis N. Safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding. Med Devices (Auckl). 2015 Mar 31;8:167-74. doi: 10.2147/MDER.S79556. eCollection 2015.

    PMID: 25878513RESULT

  • Fischer CP, Bochicchio G, Shen J, Patel B, Batiller J, Hart JC. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93. doi: 10.1016/j.jamcollsurg.2013.02.036.

    PMID: 23969113RESULT

  • Lewis KM, Li Q, Jones DS, Corrales JD, Du H, Spiess PE, Lo Menzo E, DeAnda A Jr. Development and validation of an intraoperative bleeding severity scale for use in clinical studies of hemostatic agents. Surgery. 2017 Mar;161(3):771-781. doi: 10.1016/j.surg.2016.09.022. Epub 2016 Nov 10.

    PMID: 27839931RESULT

  • Aparicio-Lopez D, Asencio-Pascual JM, Blanco-Fernandez G, Cugat-Andorra E, Gomez-Bravo MA, Lopez-Ben S, Martin-Perez E, Sabater L, Ramia JM, Serradilla-Martin M. Evaluation of the validated intraoperative bleeding scale in liver surgery: study protocol for a multicenter prospective study. Front Surg. 2023 Oct 2;10:1223225. doi: 10.3389/fsurg.2023.1223225. eCollection 2023.

    PMID: 37850041DERIVED

MeSH Terms

Conditions

Blood Loss, SurgicalLiver Neoplasms

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FACS

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 11, 2022

Study Start

July 1, 2022

Primary Completion

January 1, 2023

Study Completion

April 1, 2023

Last Updated

May 11, 2022

Record last verified: 2022-05

Locations

ES(2)